Director, Clinical Quality Assurance

Summary

Join QED Therapeutics, a BridgeBio Pharma affiliate, as their Director of Clinical Quality Assurance. Reporting to the VP of Clinical Quality Assurance, you will define and execute the Clinical Controlled Document Management strategy, supporting clinical areas in managing documents. You will champion continuous process improvement and partner with various teams. The ideal candidate possesses extensive experience in GCP, preferably within biotech/pharma, and strong Veeva administration skills. This role offers a competitive compensation and benefits package, including flexible PTO, opportunities for career advancement, and a collaborative, fast-paced environment.

Requirements

• Ability to build relationships and work collaboratively with a variety of individuals within the department, company, and vendors
• Strong negotiation skills, flexibility, and ability to provide a solution-based approach to emerging challenges
• A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs
• Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
• Proficient in discerning, high quality verbal and written communication
• Bachelor's degree in a scientific discipline or equivalent experience
• Minimum of 6 years of experience in a GCP practice area; Clinical Quality Assurance or similar role preferred
• Expertise with applicable GCP guidelines

Responsibilities

• In partnership with Clinical QA management, drive strategy and execution of the following: Clinical Controlled Document Management : Proactively define and drive Clinical Controlled Document management strategy at QED, and partner with other BBIO functions as it relates to ‘centralized’ Clinical Controlled Documents
• Develop, review, and revise Clinical Controlled Documents (eg, SOPs, Work Instructions) to ensure alignment with regulatory standards and industry best practices
• Manage Clinical Controlled Documents in accordance with format, content and style guidelines, and help ensure accuracy, consistency, and quality
• Partner with GMP QA in the management of Quality Assurance Controlled Documents
• Act as a single point of contact (SPoC) for clinical functional areas, and collaborate to manage document workflows
• Administrate Controlled Document management activities within Veeva including creation, review, approval and archiving processes
• Monitor workflow status (including follow up if any delay is noted) to document approval
• Foster a culture of continuous improvement and innovation across the organization
• C linical Project-Specific Training Design and develop project specific training programs
• Administrate training management activities within Veeva, and in partnership with existing Administrators
• Regulatory Authority Inspection Readiness: Support mock inspections, identify potential compliance gaps, and implement corrective actions, as needed
• Other duties as assigned or required

Preferred Qualifications

2+ years of experience with Veeva administration highly preferred

Benefits

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• An unyielding commitment to always putting patients first
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion